Pharmaceutical analysis is an important and integral part for the determination of quality including identity, purity and strength of the drugs. In addition, related studies and programs are needed to assure the performance of the drug products. It requires analysts to acquire a solid understanding of analytical chemistry and a thorough appreciation of pharmaceutical requirements to address these challenges. Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. This course is designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background. The topics provide comprehensive introduction to the drug development, analysis and related studies for small molecule drugs (non-biologics).

The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval to market their products. Therefore, other related supporting studies such as analytical instrument qualification, analytical life cycle management (development, validation, verification, method transfer), setting specifications, stability studies, and regulatory or compendial approval are examined.

Due to global nature of pharmaceutical industry, other quality topics on both regulatory (ICH) and compendial harmonization are also covered. These topics are valuable for scientists directly or indirectly involved with the drug development, analysis. stability studies or regulatory/compendial submissions. This course is based on a recent book entitled "Pharmaceutical Analysis for Small Molecules" by Dr. Davani which has been published by Wiley in 2017. In addition, examples and case studies will be provided based on insights and extensive experience in developing and implementing these topics in industry/pharmacopeia. Guidance and advice will also be provided based on interactions with global pharmaceutical industry, FDA and other regulatory authorities worldwide

Learning Objectives:

Drug Approval Process and Regulatory Requirements (private standards)

Pharmacopeias and Compendial Approval Process (public standards)

Compendial Harmonization Process

Chromatography System Suitability Requirements

Allowed Adjustments of Chromatographic System Parameters

Common Methods in Pharmaceutical Analysis (typically compendial)

Common Calculations for Assays and Impurities and Other Specific Tests

Analytical Instrument Qualifications including DQ, IQ, OQ, PQ

Analytical Method Validation

Analytical Method Verification

Analytical Method Transfer

Specifications including how to Handle Out-of-Specification (OOS) and Out of Trend (OOT)

Dr. Behnam Davani is an Independent Senior Consultant and Managing Director of Davani Pharmaceutical Consulting. He has a Ph.D. degree in analytical chemistry and holds an MBA degree. Dr. Davani has more than 28 years of experience in industry, compendial/regulatory science and training. He has extensive experience as faculty for the development and teaching of several compendial and cGMP courses both domestically and internationally for USP Global Education Program. Dr. Davani is also editor and author of a recent book: "Pharmaceutical Analysis for Small Molecules", published by Wiley in 2017.

Prior to forming his own consulting company in 2017, he worked at USP for 17 years in different capacities including Director of Chemical Medicine Department and the Principal Scientific Liaison. His last responsibly at USP was the scientific management of the content development and teaching of USP Education courses for stakeholders worldwide. He was also a faculty for several Pharmacopeial Education courses both domestic and internationally. These topics include validation/verification/transfer of analytical procedures, impurities in drug substances and drug products, compendial HPLC, residual solvents, spectroscopy and stability studies for pharmaceutical products. In addition, he provided scientific support to the USP International Regulatory Affairs Department and Global Public Health Department for outreach and training for international regulatory agencies. Before joining USP in 1999, Dr. Davani worked in industry in various technical management positions for more than ten years.

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